OJN · Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
· Class 3
Overview
| Product Code | OJN |
|---|---|
| Device Name | Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test |
| Device Class | Class 3 |
| Review Panel |
Identification
For the detection of effector T cells that respond to stimulation by Mycobacterium tuberculosis antigens ESAT-6 and CFP-10 and indicated for use as an aid in the diagnosis of M. tuberculosis infection in conjunction with risk assesment, radiography and other medical diagnostic evaluations.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P070006 | T SPOT-TB TEST | Oxford Immunotec, Ltd. | Jul 30, 2008 | APPR |
Top Applicants
- Oxford Immunotec, Ltd. — 1 clearance
